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Hundreds of millions of imitations! Jiankangyuan's "Asthma Inhalation Powder" approved for market
Published Time：
2024-06-14
Last week ( June 3-9), a total of 87 varieties passed/were deemed to have passed the consistency evaluation 。 Among them, Health Yuan's Salmeterol/fluticasone propionate dry powder inhaler is a first-to-market drug. At the same time, 81 varieties applied for consistency evaluation.
01
Tens of billions of annual sales
First-to-market drug launched
According to the NMPA official website, Health Yuan 's Salmeterol/fluticasone propionate dry powder inhaler on June 4th obtained a marketing approval, becoming the first domestic generic of Seretide®. This product is used for regular treatment of reversible airway obstructive airway diseases, including asthma in adults and children 。
According to reports, the salmeterol/fluticasone propionate dry powder inhaler is a combination inhaler of salmeterol and fluticasone propionate ，independently developed by Health Yuan, in a combination therapy (bronchodilator and corticosteroid). Salmeterol is a long-acting β2-agonist ，which can durably dilate the bronchi; fluticasone propionate is a corticosteroid, which can control inflammation and reduce acute attacks. The combined use of bronchodilators and corticosteroids is the gold standard for asthma treatment.
The original research product of salmeterol/fluticasone propionate dry powder inhaler is GlaxoSmithKline （ GSK) company's Seretide®, this drug is the world's first combination inhaler of bronchodilator and corticosteroid, and after its launch, it quickly became an important product for the treatment of asthma and chronic obstructive pulmonary disease Seretide ® was first approved for import in China in 2001 and is a Class B drug under the national medical insurance system. According to GSK's 2023 annual report, the global sales of Seretide® for the whole year were approximately £1.139 billion (approximately RMB 10.56 billion) 。
In addition, it is understood that among various inhalation preparations, dry powder inhalers have the greatest technical difficulty, and their particle engineering, process development, process scaling-up, and drug delivery devices are all challenging. Factors such as mixing intensity, time, temperature, and humidity may affect the air movement morphology of drug particles during the inhalation process, thereby affecting the distribution of the drug in the lungs and ultimately affecting the clinical effect. Therefore, generic dry powder inhalers are recognized as one of the most difficult challenges in the pharmaceutical industry. Although the patent for Seretide expired as early as 2013, the world's first generic salmeterol/fluticasone propionate was not approved by the FDA until February 2019, and there has never been a generic drug in China.
Health Yuan's Salmeterol/fluticasone propionate dry powder inhaler successful approval and listing is expected to break the original research's monopoly in China and provide more choices for patients.
02
Consistency Evaluation Pass Status
From June 3rd to June 9th, a total of 87 varieties passed/were deemed to have passed the consistency evaluation 。
Among them, Jiashi (Hunan) Pharmaceutical Technology Co., Ltd. /Hunan Tianji Caotang Pharmaceutical Co., Ltd.'s Compound Phosphate Granules, Wuhu Daorun Pharmaceutical Co., Ltd.'s Neutral low-calcium peritoneal dialysis solution (Bicarbonate-G2.5%) 、 Neutral peritoneal dialysis solution (Bicarbonate-G2.5%), Neutral peritoneal dialysis solution (Bicarbonate-G1.5%), Neutral peritoneal dialysis solution (Bicarbonate-G4.25%), Jiangsu Wu Zhong Chinese Medicine Group Co., Ltd. Suzhou Pharmaceutical Factory/Hunan Kolen Pharmaceutical Co., Ltd.'s Oseltamivir sodium injection etc. are the company's exclusive varieties.
Details of other varieties are as follows:
Table 1: June 3-9, varieties that passed the consistency evaluation
Data source: YaZhi Data Enterprise Edition ——Generic Drug Consistency Evaluation Analysis System Database
Table 2: June 3-9, varieties deemed to have passed the consistency evaluation
Data source: YaZhi Data Enterprise Edition ——Generic Drug Consistency Evaluation Analysis System Database
03
Consistency Evaluation Acceptance Status
From June 3rd to June 9th, a total of 81 varieties applied for consistency evaluation. Details are as follows:
Table 3: May 27-June 2, Consistency Evaluation Application Status
Data source: YaZhi Data Enterprise Edition ——Generic Drug Consistency Evaluation Analysis System Database
This article is from: YaZhi Data
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